Determining the effect of multifunctional lower limb orthosis in patients with foot drop
Design
The clinical trial is accessible to 20 patients with foot drop.
Settings and conduct
Patients who refer to the clinics of physical medicine and rehabilitation specialists affiliated to Shiraz University of Medical Sciences as well as the physiotherapy clinic of the Faculty of Rehabilitation are selected. 20 of these patients were admitted to the study with easy access and before, immediately and 3 months after using multifunctional lower limb orthosis, the patients were analyzed by Kistler force plate and Qualysis motion analysis system software. Patients are also asked to complete the SF-12 quality of life questionnaire and the lower extremity functional scale questionnaire before and 3 months after orthosis use. The data will then be collected and analyzed by SPSS software version 16.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients who were able to walk independently, needed a mobility aid, and foot drop due to a lower motor neuron disorder caused by trauma, injection, discopathy, etc. and Have not used orthoses to correct foot drop.
Intervention groups
20 patients with foot drop wear multi-purpose lower limb orthoses made in the Rehabilitation Faculty of Shiraz University of Medical Sciences.
Main outcome variables
The degree of foot drop
The rate of kinetic and kinematic changes in gait analysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210715051897N1
Registration date:2021-08-04, 1400/05/13
Registration timing:prospective
Last update:2021-08-04, 1400/05/13
Update count:0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
Mohammad Amin Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3722 1366
Email address
mohammad313amin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lower limb multifunctional orthosis in patients with foot drop
Public title
Evaluation of the effect of lower limb multifunctional orthosis in patients with foot drop
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have foot drop
Be independent in walking
Need a mobility aid
Foot drop due to damage to the lower motor neurons caused by trauma, injection, discopathy, etc
They have never used orthosis to correct foot drop
Do not have progressive neurological disease
There are no restrictions on the movement of the lower limb joints
Have no history of stroke, lower limb orthopedic surgery, rheumatic diseases, or orthopedic problems affecting gait and balance.
Can walk 10 meters without a mobility aid
Not more than 2 years have passed since the foot drop
The recovery process is not fast
Exclusion criteria:
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Secretariat of the Ethics Committee of University Research, Vice Chancellor for Research and Technology, 7th Floor, Shiraz University of Medical Sciences, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۱۳۵۶۵
Approval date
2021-01-18, 1399/10/29
Ethics committee reference number
61.IR .SUMS.MED.REC.1400
Health conditions studied
1
Description of health condition studied
foot drop
ICD-10 code
M21.37
ICD-10 code description
Foot drop (acquired)
Primary outcomes
1
Description
The degree of foot drop
Timepoint
Before and immediately and 3 months after wearing orthoses
Method of measurement
Goniometer
2
Description
The measure of kinetic and kinematic changes in walking
Timepoint
Before and immediately and 3 months after wearing orthoses
Method of measurement
Kistler force plate system and Qualysis motion analysis system software
Secondary outcomes
1
Description
Performance of Patients with foot drop
Timepoint
Before and 3 months after wearing orthoses
Method of measurement
Lower extremity functional scale questionnaire
2
Description
Quality of life score of patients with foot drop in the Short Form Health Survey questionnaire
Timepoint
Before and 3 months after wearing orthoses
Method of measurement
12-item Short Form Health Survey
Intervention groups
1
Description
Intervention group: 20 patients with foot drop wear multi-purpose lower limb orthoses made in the Rehabilitation Faculty of Shiraz University of Medical Sciences.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation
Full name of responsible person
mohammad amin vafaei
Street address
Faculty of Rehabilitation Sciences, Abivardi St. 1, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۵۱۷۳۳
Phone
+98 71 3627 1552
Email
Rehab@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
seventh floor, the central building of Shiraz University of Medical Sciences, next to the Red Crescent, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?